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Apr 17, 2006
 |  BioCentury  |  Regulation

Zero hour nears in Europe

FDA's 'Egregious' Delays

Zero hour nears in Europe

Compared to the U.S., where follow-on biologics are creeping toward the market, Europe is racing forward. European consumers could be seeing FOBs - biosimilars in Eurospeak - on pharmacy shelves this year. Sandoz Inc. CEO Andreas Rummelt told BioCentury the company expects to receive EC approval for its Omnitrope human growth hormone in the next two weeks.

In the U.S., big pharma and big biotech are continuing the fight to delay FOB competition. And while Sandoz's victory in federal court last week may accelerate FDA's action on the NDA for Omnitrope, there are likely to be many hurdles before the product is marketed in the U.S. (see Cover Story).

FDA approval would be virtually certain to elicit litigation from Pfizer Inc. (PFE, New York, N.Y.), which has stated in citizen petitions filed with FDA that approval of Omnitrope would be illegal on several grounds, including violation of trade secrecy laws.

Omnitrope, which received a CHMP recommendation in January, already is approved in Australia, where it is marketed as a low-cost version of hGH. It was approved based on similarity to a marketed product, but unlike a generic drug, it is not automatically substitutable for a pioneer product.

Omnitrope sells in Australia for 25% less than the price of pioneer...

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